FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FE-CULT PLUS
K Number: K811752
·
Decision Nov 2, 1981
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
21
Review Days
133
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Basic Information
- Device Name
- FE-CULT PLUS
- K Number
- K811752
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Gamma Biologicals, Inc.
- Date Received
- June 22, 1981
- Decision Date
- November 2, 1981
- Product Code
- KHE
- Advisory Committee
- Hematology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KHE | Reagent, Occult Blood | FDA class 2 | Hematology |
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Other Clearances by Gamma Biologicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K864207 | DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO | Dec 3, 1986 | Substantially Equivalent |
| K861016 | GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS | Apr 18, 1986 | Substantially Equivalent |
| K832473 | GAMMA SLIDE TEST FOR PREGNANCY | Aug 16, 1983 | Substantially Equivalent |
| K820647 | GAMMA FETAL BLEED SCREENING TEST | May 12, 1982 | Substantially Equivalent |
| K813342 | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | Mar 4, 1982 | Substantially Equivalent |
| K820072 | FE-CULT PLUS | Mar 4, 1982 | Substantially Equivalent |
| K802533 | GAMMA LEWIS BLOOD GROUP SUBSTANCE | Nov 12, 1980 | Substantially Equivalent |
| K802534 | GAMMA PI BLOOD GROUP SUBSTANCE | Nov 12, 1980 | Substantially Equivalent |
| K800658 | RST-SERIES CONTROL | Apr 16, 1980 | Substantially Equivalent |
| K792582 | POLY-LEC SYSTEM | Jan 16, 1980 | Substantially Equivalent |